Han Qian-Qian, Wen Zi-Yun, Lyu Qing, Pan Yun-Yun
Clinical Pharmacy Center, Nanfang Hospital, Southern Medical University Guangzhou 510515, China the First Affiliated Hospital of Guangdong Pharmaceutical University Guangzhou 510080, China.
Clinical Pharmacy Center, Nanfang Hospital, Southern Medical University Guangzhou 510515, China.
Zhongguo Zhong Yao Za Zhi. 2023 Jan;48(1):234-246. doi: 10.19540/j.cnki.cjcmm.20221018.501.
This study aimed to evaluate the efficacy and safety of Chinese patent medicines containing Hirudo in the treatment of atherosclerosis(AS) by network Meta-analysis, and to provide evidence-based reference for clinical treatment of AS. The clinical randomized controlled trial(RCT) on the treatment of atherosclerosis with Chinese patent medicines containing Hirudo were searched in CNKI, Wanfang, VIP, SinoMed, PubMed and EMbase from the establishment of the databases to July 1, 2022. And data extraction and quality assessment of the included RCT was performed according to the Cochrane standards. Stata 17 and ADDIS 1.16.5 were then used for Bayesian model network Meta-analysis. Finally, 67 RCTs with a total sample size of 6 826 cases were included, 3 569 cases in the experimental group and 3 257 cases in the control group, involving three oral Chinese patent medicines. Network Meta-analysis showed that in terms of reducing intima-media thickness(IMT), the top three Chinese patent medicines were Tongxinluo Capsules+sta-tins>Maixuekang Capsules+statins>Maixuekang Capsules. In terms of reducing plaque area, the top one was Maixuekang Capsules+sta-tins, and the other Chinese patent medicines had similar efficacy. For lowering AS Crouse scores, the top three were Maixuekang Capsules>Tongxinluo Capsules+statins>Naoxintong Capsules. For decreasing plaque number, the top three were Naoxintong Capsules+sta-tins>Tongxinluo Capsules+statins>Tongxinluo Capsules. With regard to adverse reactions/events, Naoxintong Capsules+statins had the lo-west incidence. In conclusion, in Chinese patent medicines containing Hirudo for the treatment of AS, Tongxinluo Capsules+statins, Maixuekang Capsules, Maixuekang Capsules+statins, and Naoxintong Capsules+statins were the primary choices to reduce IMT, AS Crouse scores, plaque area, and plaque number, respectively. The efficacy of Chinese patent medicines containing Hirudo with or without statins was more significant than that of statins alone in the four outcome indexes. Additionally, the treatment of AS should be evaluated comprehensively, and attention should be paid to Chinese patent medicines or their combination with western medicine, to optimize the treatment effect and minimize adverse reactions as the benchmark.
本研究旨在通过网状Meta分析评价含水蛭中成药治疗动脉粥样硬化（AS）的有效性和安全性，为AS的临床治疗提供循证参考。检索CNKI、万方、维普、中国生物医学文献数据库、PubMed及EMbase中自建库至2022年7月1日关于含水蛭中成药治疗动脉粥样硬化的临床随机对照试验（RCT）。并根据Cochrane标准进行纳入RCT的数据提取和质量评估。然后使用Stata 17和ADDIS 1.16.5软件进行贝叶斯模型网状Meta分析。最终纳入67项RCT，总样本量6826例，试验组3569例，对照组3257例，涉及3种口服中成药。网状Meta分析显示，在降低内膜中层厚度（IMT）方面，疗效前三的中成药为通心络胶囊+他汀类药物＞脉血康胶囊+他汀类药物＞脉血康胶囊。在减小斑块面积方面，疗效最佳的是脉血康胶囊+他汀类药物，其他中成药疗效相近。在降低AS Crouse积分方面，前三为脉血康胶囊＞通心络胶囊+他汀类药物＞脑心通胶囊。在减少斑块数量方面，前三为脑心通胶囊+他汀类药物＞通心络胶囊+他汀类药物＞通心络胶囊。在不良反应/事件方面，脑心通胶囊+他汀类药物的发生率最低。综上所述，在含水蛭中成药治疗AS中，通心络胶囊+他汀类药物、脉血康胶囊、脉血康胶囊+他汀类药物、脑心通胶囊+他汀类药物分别是降低IMT、AS Crouse积分、斑块面积、斑块数量的首选。在四项结局指标中，含或不含他汀类药物的含水蛭中成药疗效均优于单用他汀类药物。此外，AS的治疗应综合评估，重视中成药及其与西药的联合应用，以优化治疗效果、减少不良反应为基准。
